Reading the fine print can be a hassle, but tiny type can be a matter of life and death when it appears on prescription drug labels. That’s why it’s so disappointing the California Pharmacy Board appears poised to adopt a weak prescription drug labeling standard that puts the health of Californians at risk.
As the Institute of Medicine noted in its 2007 “Preventing Medication Errors” report, when patients have a hard time reading prescription drug names and instructions printed on medication bottles, there’s a high potential for harmful errors, especially among seniors.
A 2007 law written by state Sen. Elaine Corbett aimed to curb medication errors and improve drug regimen adherence by making prescription drug labels easier to read. The law requires the State Board of Pharmacy to enact regulations that require a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Under the law, the board is supposed to consider improved font types and sizes, placement of information that is patient-centered, improved directions for use, the needs of seniors, and the needs of patients with limited English proficiency.
It also requires maximum public comment. True to that mandate, for over a year the board held town hall meetings around the state and formal regulatory hearings in Sacramento, and received oral and written testimony from organizations representing consumers, seniors, patients, communities of color, and industry groups.
The board concluded, through a search of the academic literature, that 12-point typeface was the appropriate size. Taking all this into account, last November the board recommended a regulation that called for minimum 12-point type and increased assistance for patients with language barriers.
But just two months later, the board did an abrupt about-face, acceding to industry demands, and proposed a 10-point typeface minimum and reduced help for those with limited English skills.
What changed between November and January? Not the academic research or the needs of seniors and other consumers. The day before the January meeting, the governor appointed Deborah Veale, director of managed care for CVS Pharmacy, to the board. Veale cast the deciding vote to reject the more consumer-friendly regulation. The board then opted for a drug label standard requiring 10-point type and language interpretation only at the pharmacy’s discretion.
As the board has acknowledged, not a single piece of evidence supported their vote for the 10-point type. The American College of Physicians recommends a 12-point type minimum on prescription drug labels, and a recent report by the National Association of Boards of Pharmacy acknowledges 12-point type as the industry standard.
In New York City, an ordinance requires pharmacies to provide translation for drug labels, and national chains are already geared up for that translation. In a 2007 California Health Interview Survey by UCLA, nearly a quarter of respondents with limited English proficiency reported difficulty reading prescription labels.
The board will meet on April 22 to make its final decision on the drug labeling regulation. Since the January hearing, more than 1,000 Californians have sent letters to the board through Consumers Union’s Safe Patient Project site (www. SafePatientProject.org) in support of the original proposed regulation for minimum 12-point type. Numerous other groups representing seniors, communities of color and consumers have weighed in supporting the originally proposed regulation.
And in early March, the director of the state Department of Consumer Affairs, Brian Stiger, also weighed in urging the board to reverse its decision, stating, “We believe the minimum standard of 10-point font is inadequate.”
The board should heed the public outcry and listen to the experts. It is only common sense that drug labels that are unreadable by patients will more likely result in harmful medication errors. Californians shouldn’t have to take out a magnifying glass to read prescription drug labels. Make the labels readable. It can be a matter of life or death.